CBL-514 Injection for Reducing Subcutaneous Fat
(SUPREME-01 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called CBL-514, which aims to reduce subcutaneous belly fat. Researchers seek to determine if this injection is safe and effective compared to a placebo, a harmless solution resembling the actual treatment. It targets individuals with moderate to severe belly fat who maintain a stable lifestyle. Those with a fear of needles or certain medical conditions may not be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking any weight reduction medications, GLP-1 agonists, long-term systemic steroids, immunosuppressive therapy, and certain medications affecting CYP1A2 enzymes. If you're on these, you may need to stop them to participate.
Is there any evidence suggesting that CBL-514 injection is likely to be safe for humans?
Research has shown that CBL-514 injections are generally safe and well-tolerated. Studies indicate that CBL-514 can significantly reduce belly fat without causing major side effects. Most participants did not experience serious problems, and the treatment received positive feedback. Some mild reactions, such as slight pain or redness at the injection site, might occur, but these are usually temporary. Overall, the safety data appears promising for those considering joining a trial for CBL-514.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for reducing subcutaneous fat, which often involve surgical procedures like liposuction or non-surgical methods such as cryolipolysis, CBL-514 is a non-surgical injectable solution. Researchers are excited about CBL-514 because it breaks down fat cells through a unique chemical process, potentially offering a less invasive option with minimal recovery time. This approach could provide a more convenient and accessible alternative for individuals looking to reduce fat without undergoing surgery.
What evidence suggests that CBL-514 injection might be an effective treatment for reducing abdominal subcutaneous fat?
Research has shown that CBL-514 injections, which participants in this trial may receive, can help reduce body fat under the skin. One study found that many people lost at least 150 mL of fat within 4 to 8 weeks after receiving the treatment. Another study demonstrated that CBL-514 outperformed liposuction, with some individuals losing over 300 mL of fat. The treatment appears effective in various body areas, even with just one injection. These findings suggest that CBL-514 could be a promising option for reducing stubborn body fat.46789
Who Is on the Research Team?
Anne Sheu
Principal Investigator
Caliway Biopharmaceuticals Co., Ltd.
Are You a Good Fit for This Trial?
This trial is for individuals looking to reduce abdominal subcutaneous fat. Specific eligibility criteria are not provided, but typically participants should be healthy adults who meet certain body mass index (BMI) requirements and have a stable weight.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 4 treatments of the study drug or placebo, administered subcutaneously to the abdomen every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CBL-514 Injection
Trial Overview
The study tests the effectiveness of CBL-514 Injection compared to a placebo (0.9% Sodium Chloride). It's randomized, meaning people are put into the treatment or placebo group by chance, and double-blinded so neither participants nor researchers know who's getting what.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive CBL-514 administrated up to 120 mL (with 50 injections) per treatment at a 3-weeks interval for up to 4 treatments.
Participants will receive 0.9% Sodium Chloride administrated up to 120 mL (with 50 injections) per treatment at a 3-week interval for up to 4 treatments.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Caliway Biopharmaceuticals Co., Ltd.
Lead Sponsor
Citations
A Randomized, Phase IIa Study of CBL-514 Injection on ...
We therefore expect CBL-514 to produce favorable outcomes in subcutaneous fat reduction in other body areas, regardless of size. With only 1 injection ...
Efficacy and Safety of CBL-514 Injection in Reducing ...
The primary efficacy outcome was the proportion of participants exhibiting ≥150 mL subcutaneous fat volume loss from baseline to the 4- and 8-week follow-up ...
NCT06005441 | A Phase 2b Study to Evaluate the Efficacy ...
This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 ...
Caliway's CBL-514 Achieved Better Efficacy than ...
CBL-514 demonstrated the efficacy on subcutaneous fat reduction more effective than liposuction in the CBL-0202 stage 2 phase 2 study, reducing over 300mL of ...
Caliway to Present CBL-514 Phase 2b Study Results for ...
The data will be highlighted in both the 2025 focus session on advances in fat reduction therapies and further detailed in the Non-surgical Body ...
Efficacy and Safety of CBL-514 Injection in Reducing ...
CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, ...
NCT04698642 | A Study to Evaluate the Safety, Tolerability ...
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat.
CBL-514-R&D-Caliway Biopharmaceuticals Co., Ltd
Administered via subcutaneous injection, CBL-514 has demonstrated a favorable safety and tolerability profile, enabling significant localized fat reduction ...
ANZCTR - Registration
CBL-514 will be administered via injection into the abdominal subcutaneous adipose layer. Eligible subjects will be randomized to 1 of 3 treatment groups: ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.